Mechanical fuse for surgical implants and related methods

ABSTRACT

Devices and methods for tissue and graft procedures are provided that are designed to fail under a certain amount of force, providing sensory feedback that a particular activity may be providing too much stress on a surgical implant. For example, a surgical implant can include a sacrificial element in the form of a filament designed to break when a certain threshold value of force is met or exceeded, while a second filament that has the ability to withstand higher values of force, is able to maintain the repair after the first filament fails. In other embodiments, the sacrificial element includes a filament engagement mechanism associated with a suture anchor configured to fail at a threshold value of force, and a second filament engagement mechanism of the anchor can maintain the repair after the first one fails. Many implants configurations are provided, as are various surgical methods incorporating sacrificial elements.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of and claims priority to U.S.patent application Ser. No. 15/960,165, filed Apr. 23, 2018, andentitled “MECHANICAL FUSE FOR SURGICAL IMPLANTS AND RELATED METHODS,”the contents of which are hereby incorporated by reference herein.

FIELD

The present disclosure relates to devices, systems, and methods forsecuring a soft tissue graft to bone, and more particularly relates tosurgical implants that include a sacrificial element (sometimes referredto herein as a “mechanical fuse”) configured to proactively break andthereby produce sensory feedback in response to an applied load of thegraft exceeding a threshold while the tissue graft repair remainsintact. The sensory feedback in the form of a sound and/or uneasyfeeling can serve as a warning to the patient to avoid certain movementsor physical activity.

BACKGROUND

Joint injuries may commonly result in the complete or partial detachmentof ligaments, tendons, and soft tissues from bone. Tissue detachment mayoccur in many ways, e.g., as the result of an accident such as a fall,overexertion during a work related activity, during the course of anathletic event, or in any one of many other situations and/oractivities. These types of injuries are generally the result of excessstress or extraordinary forces being placed upon the tissues.

In the case of a partial detachment, commonly referred to under thegeneral term “sprain,” the injury frequently heals without medicalintervention, the patient rests, and care is taken not to expose theinjury to undue strenuous activities during the healing process. If,however, the ligament or tendon is completely detached from itsattachment site on an associated bone or bones, or if it is severed asthe result of a traumatic injury, surgical intervention may be necessaryto restore full (or close to full) function to the injured joint. Anumber of conventional surgical procedures exist for re-attachingtendons, ligaments or other soft tissue to bone.

One example is the knee 100 shown in FIG. 1, which includes anterior andposterior cruciate ligaments 102, 104 extending from the head of thetibia 106 to the intercondylar notch of the femur 108. These ligamentsoperate to prevent forward and backward relative motion between the twobones. When ruptured (e.g., as can happen in strenuous athleticmovements), surgical reconstruction can be necessary.

Tears in the cruciate ligaments of the knee can be repaired using aligament graft taken from a cadaver (i.e., an allograft) or from apatient's own tissue (i.e., an autograft). Reconstruction proceduresgenerally involve forming a hole in both the femur and tibia, and thensecuring opposite ends of the ligament graft in these holes. In onecruciate ligament repair procedure, a ligament graft is associated witha surgical implant and secured to the femur. A common femoral fixationmeans includes an elongate body, sometimes referred to as a corticalbutton or “button.” The cortical button is attached to a suture loopthat is sized to allow an adequate length of a soft tissue graft to liewithin the femoral tunnel while providing secure extra-corticalfixation.

Another surgical procedure may involve arthroscopic knot tying, which iscommonly practiced in shoulder rotator cuff and instability procedures.Typically, an anchor loaded with suture is first attached to bone. Thesuture is normally slidably attached to the anchor through an eyelet oraround a post, such that a single length of suture has two free limbs.One limb of the suture is passed through soft tissue to be repaired suchas a tendon or labrum. The two ends of the suture are then tied to eachother, thereby capturing the soft tissue in a loop with the anchor. Upontightening the loop, the soft tissue is approximated to the bone via theanchor.

As with any surgical procedure, a repaired tendon, ligament, or othersoft tissue needs time to heal. However, it is not uncommon for apatient to start feeling better relatively soon after the repair orreconstruction procedure. If a patient attempts to resume rigorousphysical activity too soon after the procedure and/or the patient is tooaggressive in performing their post-operative rehabilitation, there is arisk that the repair of the tendon, ligament, or other soft tissue mayfail. For example, the suture loop can post-operatively loosen, slip,and/or break, causing the tissue graft to move away from the desiredlocation.

Accordingly, there is a need for improved surgical implants and methodsfor use in repair and reconstruction procedures that producepost-operative sensory feedback in response to patient movements orother activity that may cause potential failure of a repaired tendon,ligament or other soft tissue.

SUMMARY

The present disclosure provides for surgical implants, and methods ofusing the same, having a sacrificial element, also referred to as amechanical fuse, designed to fail at a certain threshold value of forceto provide sensory feedback that an action causing a force that meets orexceeds the certain threshold value is likely providing force that isdetrimental to the surgical implant The sacrificial element is designedto break or otherwise fail to indicate that the threshold value has beenmet or exceeded, and then the portion of the implant, or tissue or graftassociated with the same, can be maintained by a nearby component of theimplant that is designed to capture the object that had previously beenassociated with the sacrificial element to prevent total failure of theimplant. The nearby component typically has a higher threshold valuethan the sacrificial element so it does not fail under similarcircumstances. In some instances the sacrificial element includes asacrificial filament (or other similar component or equivalent, asdiscussed herein) that is designed to hold a graft, tissue, or the likewith respect to an implantable body, and when the sacrificial filamentfails, a second filament associated with the implantable body, referredto herein as a repair filament, is configured to receive the graft,tissue, or the like that was being held by the implantable body. In someother instances the sacrificial element includes a sacrificial sutureengagement mechanism that is part of a suture anchor. The sacrificialsuture engagement mechanism is designed to maintain a repair filamentcoupled to the suture anchor, with the repair filament being used in arepair procedure, such as for capturing and drawing tissue towards boneas part of a soft tissue repair. When the sacrificial suture engagementmechanism fails due to the application of a force by the repair filamentthat meets or exceeds the threshold value of the sacrificial sutureengagement mechanism, a filament engagement mechanism that is also partof the suture anchor can be designed to capture the repair filament sothat the repair filament remains close to its original location withrespect to the suture anchor when the repair had been completed.

One exemplary embodiment of a surgical implant includes an implantablebody, a repair filament, and a sacrificial element. The implantable bodyhas at least one passageway extending at least partially through thebody. The repair filament is disposed in the at least one passageway,and forms a repair loop configured to connect the implantable body and atissue. The repair filament has a first maximum load-bearing capacity.The sacrificial element is associated with the implantable body and/orthe sacrificial element. The sacrificial element is configured to carryan applied load of the repair filament and/or the tissue, and has asecond maximum load-bearing capacity. The second maximum load-bearingcapacity is lower than the first maximum load-bearing capacity of therepair filament such that the sacrificial element is configured toproduce sensory feedback in response to the applied load of the repairfilament and/or the tissue exceeding the second maximum load-bearingcapacity.

In some embodiments, the sacrificial element can include a sacrificialfilament. In some such embodiments, the at least one passageway caninclude at least two passageways, with each passageway extending betweena proximal end and a distal end of the implantable body. Further, eachof the repair filament and the sacrificial filament can extend througheach of the at least two passageways such that each of the repairfilament and the sacrificial filament is disposed above a top side ofthe implantable body and below a bottom side of the implantable body,the top and bottom sides being opposed to each other. The sacrificialfilament can form a sacrificial loop configured to produce the sensoryfeedback in response to an applied load from the tissue when the appliedload exceeds the second maximum load-bearing capacity of the sacrificialfilament. In some such embodiments, the sensory feedback can beassociated with the sacrificial loop breaking in response to the appliedload from the tissue when the applied load exceeds the second maximumload-bearing capacity of the sacrificial filament. Alternatively, oradditionally, a circumference formed by the sacrificial loop can besmaller than a circumference formed by the repair loop. In someembodiments that include a sacrificial filament, the second maximumload-bearing capacity of the sacrificial filament can be approximatelyone half of the first maximum load-bearing capacity of the repairfilament.

A number of other configurations involving a sacrificial filament arealso provided. For example, the sacrificial filament can be configuredto form a sacrificial loop disposed approximately transverse to therepair loop, with the sacrificial loop constricting opposing sides ofthe repair loop at a location between the implantable body and a distalend of the repair loop. In some such embodiments, the sensory feedbackcan be associated with the sacrificial loop breaking in response to theopposing sides of the repair loop stretching the sacrificial loop untilthe second maximum load-bearing capacity of the sacrificial filament isexceeded.

By way of further non-limiting example, the sacrificial filament can beconfigured to form one or more sacrificial stitches that can connectopposing sides of the repair loop at a location between the implantablebody and a distal end of the repair loop. In some such embodiments, thesensory feedback can be associated with at least one sacrificial stitchof the one or more sacrificial stitches breaking in response to theopposing sides of the repair loop stretching the at least onesacrificial stitch until the second maximum load-bearing capacity of thesacrificial filament is exceeded.

By way of still further non-limiting example, the sacrificial filamentcan be integrated with (or otherwise associated with, as provided forherein) the repair filament to form a sacrificial loop integrated withthe repair loop. In some such embodiments, the sensory feedback can beassociated with the sacrificial loop breaking while the repair loopremains intact in response to the tissue applying a load greater thanthe second maximum load-bearing capacity of the sacrificial filament andless than the first maximum load-bearing capacity of the repairfilament.

Alternatively, or additionally, the sacrificial element can include asacrificial weld that connects opposing sides of the repair loop at alocation between the implantable body and a distal end of the repairloop. In some such embodiments, the sensory feedback can be associatedwith the sacrificial weld breaking in response to the opposing sides ofthe load-bearing loop stretching the sacrificial weld until the secondmaximum load-bearing capacity of the sacrificial weld is exceeded.

In some other embodiments, the implantable body can include a sutureanchor and the sacrificial element can include an element that is partof the suture anchor. Such embodiments can further include a sacrificialelement that includes a sacrificial filament, while other suchembodiments may not include a sacrificial element that includes asacrificial filament. More particularly, the suture anchor can includeboth a filament engagement mechanism and the sacrificial element thatincludes a sacrificial filament engagement mechanism. In some suchembodiments, the sacrificial filament engagement mechanism can bedistally spaced apart from the filament engagement mechanism, with asecond maximum load-bearing capacity of the sacrificial filamentengagement mechanism being lower than a maximum load-bearing capacity ofthe filament engagement mechanism. Further, the repair filament can bedisposed at least partially around each of the filament engagementmechanism and the sacrificial filament engagement mechanism, with adistal-most portion of the repair filament being engaged with thesacrificial filament engagement mechanism. The sensory feedback can beassociated with the sacrificial filament engagement mechanism breakingin response to the repair filament applying a force against thesacrificial filament engagement mechanism that exceeds the secondmaximum load-bearing capacity of the sacrificial filament engagementmechanism.

An exemplary method of using a surgical implant that includes asacrificial element includes performing a tissue repair procedure thatresults in an implantable body being disposed at a surgical locationsite, with the implantable body having a repair filament coupled to it,and a sacrificial element associated with the implantable body. Thetissue repair procedure results in tissue being disposed at a desiredlocation with respect to bone in the body. The sacrificial element isconfigured to carry an applied load of at least one of the repairfilament and the tissue. The repair filament has a first maximumload-bearing capacity, and the sacrificial element has a second maximumload-bearing capacity that is lower than the first maximum load-bearingcapacity of the repair filament. Further, the sacrificial element isconfigured to produce sensory feedback in response to the applied loadof the respective tissue and the repair filament exceeding the secondmaximum load-bearing capacity of the sacrificial element after thetissue repair procedure has been completed. As discussed in greaterdetail below, the sacrificial element can take a variety of forms,including but not limited to a sacrificial filament and a sutureengagement mechanism that is part of a suture anchor. Likewise, thetissue can be tissue in the body and/or a graft.

In some embodiments, the sacrificial element can include a sacrificialfilament coupled to the implantable body and the tissue can include agraft. In some such embodiments, the action of performing a tissuerepair procedure can include coupling the graft to the sacrificialfilament. The sacrificial filament can be configured to produce thesensory feedback in response to the applied load of the graft to thesacrificial filament exceeding the second maximum load-bearing capacityof the sacrificial filament. For example, the sensory feedback can bethe sacrificial filament breaking. In some such embodiments, thesacrificial filament can include a sacrificial loop and the action ofcoupling the graft to the sacrificial filament can include disposing thegraft within the sacrificial loop such that the graft is in contact withthe sacrificial loop.

In some other embodiments, the sacrificial element can include asacrificial filament that is associated with the repair filament, therepair filament can include a repair loop, and the tissue can include agraft. In some such embodiments, the action of performing a tissuerepair procedure can include coupling the graft to the repair filament.The sacrificial filament can be configured to produce the sensoryfeedback in response to opposing sides of the repair loop stretching thesacrificial filament until the second maximum load-bearing capacity ofthe sacrificial filament is exceeded. In some such embodiments, thesacrificial filament can include a sacrificial loop disposedapproximately transverse to the repair loop such that the sacrificialloop constricts opposing sides of the repair loop at a location betweenthe implantable body and a distal end of the repair filament.Alternatively, or additionally, the sacrificial filament can include oneor more sacrificial stitches that connect opposing sides of the repairloop.

In still some other embodiments, the sacrificial element can include asacrificial filament integrated with (or otherwise associated with, asprovided for herein) the repair filament, with the sacrificial filamentforming a sacrificial loop and the repair filament forming a repairloop. The sacrificial loop and the repair loop can also be integrated toform an integrated loop, and the tissue can include a graft. In somesuch embodiments, the action of performing a tissue repair procedure caninclude disposing the graft within the integrated loop with the graftbeing in contact with the integrated loop. The sacrificial loop can beconfigured to produce the sensory feedback in response to the appliedload of the graft exceeding the second maximum load-bearing capacity ofthe sacrificial loop such that the sacrificial loop breaks while therepair loop remains intact, thus allowing the graft to remain disposedwithin the repair loop after the sacrificial loop breaks.

In yet some other embodiments, the repair filament can include a repairloop, the sacrificial element can include a sacrificial weld thatconnects opposing sides of the repair loop, and the tissue can include agraft. In some such embodiments, the action of performing a tissuerepair procedure can include disposing the graft within the repair loop.The sacrificial weld can be configured to produce the sensory feedbackin response to the opposing sides of the repair loop stretching thesacrificial weld until the second maximum load-bearing capacity of thesacrificial filament is exceeded.

The sacrificial element can also be something other than a sacrificialfilament. For example, the sacrificial element can be part of theimplantable body. In such embodiments, a sacrificial filament may or maynot also be used in conjunction with the sacrificial element that ispart of the implantable body. In some embodiments, the implantable bodycan include a suture anchor that includes both the sacrificial elementand a filament engagement mechanism. The sacrificial element can includea sacrificial filament engagement mechanism, and the repair filament canbe coupled to the sacrificial filament engagement mechanism. In somesuch embodiments, the action of performing a tissue repair procedure caninclude disposing the implantable body in bone, coupling the repairfilament to tissue, and advancing the tissue towards the bone in whichthe implantable body is disposed. The sacrificial filament engagementmechanism can be configured to produce the sensory feedback in responseto the applied load of the repair filament to the sacrificial filamentengagement mechanism exceeding the second maximum load-bearing capacityof the sacrificial filament engagement mechanism.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate exemplary embodiments, andtogether with the background and summary given above and the detaileddescription given below, serve to explain the features of the variousembodiments. The drawings include:

FIG. 1 illustrates the anatomy of a human knee;

FIG. 2 is a perspective view of one exemplary embodiment of a surgicalimplant that includes a cortical button, a repair filament forming anouter repair loop, and a sacrificial filament forming an innersacrificial loop;

FIG. 3A is a top perspective view of the cortical button of FIG. 2;

FIG. 3B is an end elevational view of the cortical button of FIG. 3A;

FIG. 3C is a side elevational view of the cortical button of FIG. 3A;

FIG. 4A illustrates a schematic cross-sectional side view of thesurgical implant of FIG. 2 when the inner sacrificial loop is intact;

FIG. 4B illustrates a schematic cross-sectional side view of thesurgical implant of FIG. 4A when the inner sacrificial loop is broken;

FIG. 5A illustrates a schematic cross-sectional side view of oneexemplary embodiment of a surgical implant that includes a corticalbutton, a repair loop, and a sacrificial loop disposed transversely tothe repair loop;

FIG. 5B illustrates a schematic cross-sectional side view of thesurgical implant of FIG. 5A when the transversely disposed sacrificialloop is broken;

FIG. 6A illustrates a schematic cross-sectional side view of oneexemplary embodiment of a surgical implant that includes a corticalbutton, a repair loop, and a sacrificial stitch between opposing sidelegs of the repair loop;

FIG. 6B illustrates a schematic cross-sectional side view of thesurgical implant of FIG. 6A when the sacrificial stitch is broken;

FIG. 7A illustrates a schematic cross-sectional side view of oneexemplary embodiment of a surgical implant that includes a corticalbutton, a repair loop, and a sacrificial weld between opposing side legsof the repair loop;

FIG. 7B illustrates a schematic cross-sectional side view of thesurgical implant of FIG. 7A when the sacrificial weld is broken;

FIG. 8A illustrates a schematic cross-sectional side view of oneexemplary embodiment of a surgical implant that includes a corticalbutton and an integrated repair loop formed by integrating a repairfilament and a sacrificial filament;

FIG. 8B illustrates a schematic cross-sectional side view of thesurgical implant of FIG. 8A when the sacrificial filament of theintegrated repair loop is broken;

FIG. 9A illustrates a schematic cross-sectional side view of oneexemplary embodiment of a surgical implant that includes a suture anchorhaving a filament engagement mechanism and a sacrificial filamentengagement mechanism; and

FIG. 9B illustrates a schematic cross-sectional side view of thesurgical implant of FIG. 9A when the sacrificial filament engagementmechanism is broken.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present disclosure is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present disclosure. Sizes and shapes of the devices, andthe components thereof, can depend on a variety of factors, includingbut not limited to an anatomy and tendencies of the subject (i.e.,patient) in which the devices will be used, the size and shape ofcomponents with which the devices will be used, the methods andprocedures in which the devices will be used, and the preferences of thesurgeon operating the devices and/or otherwise performing the relatedprocedure(s).

In the present disclosure, like-numbered and/or like-named (e.g.,sacrificial filament, sacrificial loop, sacrificial stitch, sacrificialweld, etc.) components of the embodiments generally have similarfeatures and/or purposes, unless stated otherwise. To the extent arrowsare used to describe a direction a component can be tensioned or pulled,these arrows are illustrative and in no way limit the direction therespective component can be tension or pulled. A person skilled in theart will recognize other ways and directions for creating the desiredtension or movement. Likewise, while in some embodiments movement of onecomponent is described with respect to another, a person skilled in theart will recognize that other movements are possible. To the extentfeatures or steps are described herein as being a “first feature,”“first loop,” or “first step,” or a “second feature,” “second loop,” or“second step,” such numerical ordering is generally arbitrary, and thussuch numbering can be interchangeable. Additionally, a number of termsmay be used throughout the disclosure interchangeably but will beunderstood by a person skilled in the art. By way of non-limitingexample, the terms “suture” and “filament” may be used interchangeably,and in some instances, simultaneously. Further, use of a term like“tissue” may encompass a variety of materials, including but not limitedto ligaments, tendons, grafts, and/or other soft tissue disposed in thebody.

The present disclosure generally relates to surgical implants for use inreconstructive procedures such as tendon, ligaments, or other softtissue repairs that includes an implantable body, a repair filamentcoupled to the implantable body, and a sacrificial element, alsoreferred to as a mechanical fuse, associated with one or both of theimplantable body and the repair filament. In some embodiments, theimplantable body can be a cortical button, a suture anchor, or othertissue graft fixation devices. The repair filament can be configured toform one or more repair loops or other repair constructs for connectingthe implantable body to a tissue graft. The sacrificial element that isat the heart of the present disclosure can take a variety of forms,including but not limited to a sacrificial filament and a sacrificialfilament engagement mechanism (e.g., saddle, post), among othersacrificial constructs that are provided for herein or are otherwisederivable from the present disclosures. The sacrificial element isconfigured to have a lower load-bearing capacity than the repairfilament so that the sacrificial element breaks proactively in responseto an applied load of a tissue graft exceeding a threshold that does notbreak the repair filament or any other part of the repair mechanism.When the sacrificial element breaks, the patient may hear, feel orotherwise experience sensory feedback, e.g., a popping sound and/or anuneasy feeling or sensation. Because the sacrificial element isconfigured to break at lower loads than the repair filament, the repairfilament can remain intact when the sacrificial element breaks, suchthat the tissue graft repair is maintained. Accordingly, the sensoryfeedback produced by the sacrificial element breaking can serve aswarning to the patient to avoid certain movements or physical activityor risk failure of the tissue graft repair. The warning may also causepatients to seek out medical attention or advice.

FIG. 2 is a perspective view of one exemplary embodiment of a surgicalimplant 200 that includes a sacrificial element. In the illustratedembodiment, the surgical implant 200 includes a cortical button orimplant body 210, a repair filament 220, and a sacrificial filament 230,also referred to as a mechanical fuse. The repair filament 220 can beconfigured to form one or more outer repair loops 222 and thesacrificial filament 230 can be configured to form one or more innersacrificial loops 232 such that each loop has a proximal end coupled tothe cortical button 210 and a distal end surrounding a ligament, tendon,or other soft tissue graft 202. The repair loop 222 and the sacrificialloop 232 can be formed using any known technique for securing a tissuegraft to bone using one or more loops of suture filament coupled to acortical button or other implantable body. Such techniques can include,but are not limited to, the techniques disclosed in U.S. Pat. Nos.9,757,113, 9,888,998, U.S. Patent Application Publication No.2014/0257346, U.S. Patent Application Publication No. 2015/0157449, andU.S. Patent Application Publication No. 2016/0157851, the contents ofeach which is incorporated by reference herein in its entirety. Theabove-referenced disclosures incorporated by reference are primarilydirected to a variety of cortical button configurations, all of whichcan be used in conjunction with the disclosures provided for hereinrelated to sacrificial elements. As also provided for herein, othertypes of implantable bodies, including but not limited many differentvarieties of bone or suture anchors, can likewise be used in conjunctionwith the disclosures provided for herein related to sacrificialelements.

A cortical button 210 for use as a part of a surgical implant to fixatea soft tissue graft in bone is illustrated in FIGS. 3A-3C. The button210 can have a somewhat rectangular, elongate shape with curved leadingand trailing terminal ends 312, 314. Multiple thru-holes or passageways316 can extend from a first, top surface 320 and through a second,bottom surface 322. In the illustrated embodiment there are two outerthru-holes 316 a, 316 d disposed, respectively, adjacent to leading andtrailing terminal ends 312, 314, and two inner thru-holes 316 b, 316 cdisposed between the two outer holes 316 a, 316 d. As shown, the outerand inner thru-holes 316 a, 316 d and 316 b, 316 c have diameters thatare substantially the same, and a space separating adjacent thru-holes316 is substantially the same for each adjacent pair. A width W of thebutton 210 is defined by the distance between the two elongate sidewalls324, 326, as shown in FIG. 3B, a length L of the button 210 is definedby the distance between central portions 312 c, 314 c of the end wallsof the leading and trailing terminal ends 312, 314, as shown in FIG. 3C,and a thickness T of the button 210 is defined by the distance betweenthe top and bottom surfaces 320, 322, as shown in FIGS. 3B and 3C.

In one exemplary embodiment of the substantially rectangular button, thelength L of the body of the cortical button is in the range of about 5millimeters to about 30 millimeters, the width W is in the range ofabout 1 millimeter to about 10 millimeters, and the thickness T is inthe range of about 0.25 millimeters to about 3 millimeters. In oneexemplary embodiment, the length L can be about 12 millimeters, thewidth W can be about 4 millimeters, and the thickness T can be about 1.5millimeters. Diameters of the thru-holes 324 can be in the range ofabout 0.5 millimeters to about 5 millimeters, and in one exemplaryembodiment each can be about 2 millimeters.

Although in the illustrated embodiment each of the thru-holes 316 a, 316b, 316 c, 316 d has a substantially similar diameter, in otherembodiments some of the thru-holes can have different diameters.Additionally, any number of thru-holes can be formed in the button 210,including as few as two. In exemplary embodiments the button 210 can bemade from a stainless steel or titanium, but any number of polymers,metals, or other biocompatible materials in general can be used to formthe body. Some non-limiting examples of biocompatible materials suitablefor forming the body include a polyether ether ketone (PEEK),bioabsorbable elastomers, copolymers such as polylacticacid-polyglycolic acid (PLA-PGA), and bioabsorbable polymers such aspolylactic acid. The button 210 can also be formed of absorbable andnon-absorbable materials.

A person skilled in the art will recognize that the cortical button 210described herein is merely one example of a button or other implantablebody that can be used in conjunction with the teachings provided herein.A button or other implantable body configured to be associated withsuture filaments of the type described herein can have a variety ofdifferent shapes, sizes, and features, and can be made of a variety ofdifferent materials, depending, at least in part, on the othercomponents with which it is used, such as the suture filament and thesoft tissue graft, and the type of procedure in which it is used. Thus,while in the present embodiment the button 210 is somewhat rectangularhaving curved ends, in other embodiments the body can be substantiallytubular, among other shapes. The various configurations of corticalbuttons incorporated by reference above are just some non-limitingexamples of possible cortical button configurations and set-ups that canbe adapted to include or otherwise be used with one or more sacrificialelements.

Each of the repair filament 220 and the sacrificial filament 230 can bean elongate filament, and a variety of different types of suturefilaments can be used, including but not limited to a cannulatedfilament, a braided filament, more broadly an integrated filament (e.g.,any manufactured integration or combination of two or more filaments orfilament limbs), and a mono filament. Further, the elongate filamentneed not be a suture, as in some instances the elongate filament can bea tape or other elongate repair construct known to those skilled in theart. The type, size, and strength of the respective filaments 220, 230can depend, at least in part, on the other materials of the implant,including the material(s) of the cortical button and the graft, tissue,bone, and related tunnels through which they will be passed, the type ofprocedure in which they are used, the anatomy and tendencies of thepatient, and the preferences of the surgeon, among other factors. Theamount and type of bioabsorbable material, if any, utilized in thefilaments of the present disclosure may likewise be a matter of surgeonpreference for the particular surgical procedure to be performed, based,at least in part, on the anatomy and tendencies of the patient.

As illustrated in FIGS. 4A and 4B, the sacrificial filament 230 can beconfigured to have a lower load-bearing capacity than the repairfilament 220 so that the sacrificial loop 232 proactively breaks inresponse to an applied load of a tissue graft exceeding a threshold thatdoes not break the repair loop 222 or button 210. When the innersacrificial loop 232 breaks, the patient may hear, feel, or otherwiseexperience sensory feedback in the form of a popping sound and/or anuneasy feeling or sensation. Because the sacrificial filament 230 breaksat lower loads than the repair filament 220, the repair loop 222 canremain intact when the sacrificial loop 232 breaks and thereby maintainthe attachment of the cortical button 210 and the tissue graft 202.Accordingly, the sensory feedback associated with the sacrificialfilament can serve as warning to the patient to avoid certain movementsor physical activity that can cause the tissue graft repair to fail. Thewarning may also cause patients to seek out medical attention or advice.

FIG. 4A illustrates a schematic cross-sectional side view of thesurgical implant of FIG. 2 with the inner sacrificial loop 232 intact.As shown, the inner sacrificial loop 232 can include a proximal end 402formed by extending the sacrificial filament 230 along a top surface 320of the cortical button 210, a first side leg 404 formed by thesacrificial filament 230 extending from the top surface 320 through afirst thru-hole 316 b towards the tissue graft 202, a distal end 406formed by the sacrificial filament 230 extending around a distal surfaceof the tissue graft 202, and a second side leg 408 formed by thesacrificial filament 230 extending from the tissue graft 202 to thebottom surface 322 of the button and through a second thru-hole 316 c tocomplete the loop. A person skilled in the art will recognize otherterminology that may be appropriate to use to describe the variousportions of the loop 232, or other loops provided for herein (e.g., therepair loop 222), and thus usage of terms like proximal and distal endand legs throughout the present application are by no means limiting.

The repair loop 222 forms an outer loop around the inner sacrificialloop 232 and the tissue graft 202. For example, in the illustratedembodiment, the repair loop 222 can include a proximal end 412 formed bythe repair filament 220 extending along a top surface 320 of thecortical button 210, a first side leg 414 formed by the repair filament220 extending from the top surface 320 through the first thru-hole 316 btowards the tissue graft 202, a distal end 416 formed by the repairfilament 220 extending around the distal end 406 of the innersacrificial loop 232, and a second side leg 418 formed by the repairfilament 220 extending from the tissue graft 202 to the bottom surface322 of the button and through the second thru-hole 316 c to complete theloop.

In some embodiments, the inner sacrificial loop 232 can have a smallercircumference than the circumference of the outer repair loop 222. Thesmaller circumference of the inner sacrificial loop 232 can form a gap Hbetween the respective distal ends 406, 416 of the sacrificial loop andthe repair loop. For example, as shown in FIG. 4B, when the sacrificialloop 232 breaks, the tissue graft 202 can be released distally throughthe gap until captured by the distal end of the outer repair loop 222,and thereby cause the patient to feel or sense a slight movement of thetissue graft 202. The height of the gap H can be sized so that patientcan sense the movement of the tissue graft 202 when the sacrificial loopbreaks, but does not compromise the integrity of the repair itself. Insome embodiments, the height of the gap can be approximately in therange between about 0.1 mm and about 1 mm.

The sacrificial filament 230 is configured to have a maximumload-bearing capacity that is lower than the maximum load-bearingcapacity of the repair filament 220. The respective load-bearingcapacities of the repair filament 220 and the sacrificial filament 230can be defined as the maximum stress (e.g., force) or strain (e.g.,deformation) that the respective filament can stand without breaking,rupturing, or otherwise failing. For example, when the tissue graft 202pulls in a direction away from the cortical button 210, in a directionD, the graft exerts a force on the distal end 406 of the sacrificialloop 232 that causes the loop to stretch. Once the applied force of thetissue graft 202 exceeds the maximum load-bearing capacity of thesacrificial filament 230, the sacrificial loop 232 breaks. This can alsobe referred to as a threshold force, which is the minimum amount offorce that can be applied to the sacrificial filament to cause it tobreak. Forces greater than the threshold force may also cause thesacrificial filament to break, while forces less than the thresholdforce are not, at least alone, large enough to cause the sacrificialfilament to break.

Because the sacrificial filament 230 is configured to break at loadsthat do not break the repair filament 220, the sacrificial loop 232 canbreak while the repair loop 222 remains intact and thereby maintain theattachment between the cortical button 210 and the tissue graft 202. Insome embodiments, the sacrificial filament 230 can be configured to havea lower maximum load-bearing capacity by using a filament materialhaving a modulus of elasticity that is less than the modulus ofelasticity of the repair filament 220. Additionally or alternatively,the sacrificial filament 230 can be configured to have a lower maximumload-bearing capacity by using a sacrificial filament having a diameteror thickness that is smaller than the diameter or thickness of therepair filament 220. A person skilled in the art, in view of the presentdisclosures, will understand other properties of the sacrificial andrepair filaments that can be different so as to allow the sacrificialfilament to break while the repair filament remains impact, includingbut not limited to the type of material used to make the two filamentsand/or the configurations of the two filaments (e.g., braided vs. notbraided). Such teachings related to how to achieve different maximumload-bearing capacities and/or threshold force values for repairfilaments/loops and sacrificial filaments/loops are applicable to eachof the embodiments provided for herein (e.g., FIGS. 5A and 5B, 6A and6B, 7A and 7B, and 8A and 8B).

When the sacrificial loop 232 breaks, the patient may hear, feel, orotherwise experience some form of sensory feedback. For example, in someembodiments, the sensory feedback may be a sound (e.g., a popping sound)from the sacrificial loop breaking. In some embodiments, the patient mayfeel a slight movement of the tissue graft 202 in response to the graftbeing released from the inner sacrificial loop 232 to the outer repairloop 222, the movement resulting from the graft becoming engaged withthe outer repair loop 222. Thus, the sensory feedback associated withthe sacrificial loop 232 breaking can serve as a warning that thepatient's physical activity or movements may risk failure of the tissuegraft repair.

Although the illustrated embodiment provides for a single sacrificialloop 232, a person skilled in the art will appreciate that thesacrificial loop 232 can include a plurality of loops, just as therepair loop 222 can include a plurality of loops. Thus, the term “loop”is not limited to a single loop, and can include a plurality of loops.In instances in which the sacrificial loop 232 includes a plurality ofloops, the loops can have similar threshold forces such that the loopsare configured to break at about the same force value, or they can havegraduated threshold forces such that different loops are configured tobreak at different force values. In an instance in which the loopshaving different threshold force values, a first loop may be configuredto break at a first threshold force and a second loop may be configuredto break at a second threshold force, with the second threshold forcebeing greater than the first threshold force. This can allow formultiple warnings or triggers to be communicated to the subject based onthe amount of force applied to the sacrificial loop 232.

The present disclosure also provides for a variety of non-limitingexamples of sacrificial filament configurations. By way of example,FIGS. 5A and 5B illustrate a sacrificial filament that includes asacrificial loop 502 associated with the repair loop 222. As shown, asurgical implant 500 includes the cortical button or body 210, therepair loop 222, and the sacrificial loop 502 disposed transversely tothe repair loop 222. In the illustrated embodiment of FIG. 5A, therepair loop 222 can include the proximal end 412 extending along the topsurface 320 of the cortical button 210, the first side leg 414 extendingfrom the top surface 320 through the first thru-hole 316 b towards thetissue graft 202, the distal end 416 extending around the distal surfaceof the tissue graft 202, and the second side leg 418 extending from thetissue graft 202 to the bottom surface 322 of the button and through thesecond thru-hole 316 c to complete the loop.

As shown, the sacrificial loop 502 is associated with the repair loop222. More particularly, the sacrificial loop 502 can be associated withthe repair loop 222 at a location between the bottom surface 322 of thecortical button 210 and a proximal surface of the tissue graft 202captured within the repair loop 222. Further, the sacrificial loop 502can be disposed approximately transverse to the repair loop 222 suchthat the sacrificial loop 502 is approximately perpendicular to alongitudinal axis L extending approximately centrally through theimplant 500. The longitudinal axis L is substantially parallel to alength of the thru-holes 316 b and 316 c of the body 210 (and thuslongitudinal axes thereof, which are not drawn, but understood by aperson skilled in the art) and disposed approximately centrallytherebetween. The sacrificial loop 502 can be configured to have acircumference or width that constricts the opposing side legs 414 and418 of the repair loop 422. Although in the illustrated embodiment asingle sacrificial loop 502 is shown, in other instances the sacrificialloop 502 can include a plurality of loops. Thus, reference to a “loop”is by no means limiting to a single loop. In other embodiments, thesacrificial loop 502 can include a plurality of loops.

The sacrificial loop 502 can be formed in a variety of ways. By way ofnon-limiting example, in some embodiments the sacrificial loop 502 canbe formed by tying terminal portions of the sacrificial filament aroundthe opposing side legs 414 and 418 of the repair loop 222 until thecircumference of the sacrificial loop 502 constricts the legs a desiredamount. A person skilled in the art will recognize many other ways bywhich the sacrificial loop can be formed, including but not limited totying terminal portions of the sacrificial filament together to form thesacrificial loop that can constrict the desired amount, or thesacrificial loop being pre-formed as a continuous loop having a sizethat can constrict the desired amount, or the sacrificial loop includingone or more connectors that can hold one portion of the sacrificialfilament used to form the loop 502 with respect to another portion offilament, thereby forming the sacrificial loop. In some instances, a kitcan be provided having different types of sacrificial elements,including sacrificial loops that provide varying levels of constriction.

The desired amount of constriction can be defined by an amount of spaceS disposed between the opposing side legs 414, 418 of the repair loop222. The space S is smaller than a space would exist between the sidelegs 414, 418 if no sacrificial element was associated with the repairloop 222. In some instances, it may be desirable for there to be nospace therebetween such that the legs 414 and 418 are in contact at alocation at which the sacrificial loop 502 is disposed. In otherinstances, such as the instance illustrated in FIG. 5A, the legs 414 and418 are constricted by the sacrificial loop 502 without touching, havingthe space S, sometimes referred to as a gap, disposed therebetween.

The sacrificial loop 502 can be configured to have a maximumload-bearing capacity that is lower than the maximum load-bearingcapacity of the repair loop 222 so that the sacrificial loop proactivelybreaks before the repair loop fails. For example, when the tissue graft202 pulls in a direction away from the cortical button 210, in adirection D′, the graft exerts a force on the distal end 406 of therepair loop 222 that causes the repair loop to stretch both distally andlaterally. As the repair loop 222 is stretched laterally, theconstricted side legs 416, 418 exert opposing forces against thetransversely disposed sacrificial loop 502, thereby causing thesacrificial loop 502 to be stretched in opposite directions. Once theapplied force exceeds the maximum load-bearing capacity of thesacrificial loop 502, the loop breaks and causes the patient to hear,feel or otherwise experience sensory feedback, e.g., a popping soundand/or an uneasy feeling or sensation, while the repair loop 222 remainsintact. The earlier description of a threshold force is equallyapplicable to this embodiment, and all embodiments in which a maximumload-bearing capacity is discussed.

Further, in instances in which the sacrificial loop 502 includes aplurality of loops, the plurality of loops can have a variety ofconfigurations, such as those described above with respect to thesacrificial loop 232 having multiple loops. For example, the pluralityof loops can of the sacrificial loop can have similar threshold forcevalues or they can have graduated threshold force values where differentloops are configured to break under different values of force, thusproviding for multiple warnings or triggers to be communicated to thesubject based on the amount of force applied to the sacrificial loop502.

Another non-limiting example of a sacrificial filament configuration isprovided for in FIGS. 6A and 6B, in which the sacrificial filamentincludes a sacrificial stitch 602 associated with the repair loop 222.As shown, a surgical implant 600 includes the cortical button or body210, the repair loop 222, and the sacrificial stitch 602 disposed ineach of the opposing side legs 414, 418 of the repair loop 222. Thesurgical implant 600 is similar to the surgical implant 500 as shown anddescribed above with respect to FIGS. 5A and 5B, however, thesacrificial filament is used to form the sacrificial stitch 602 toconstrict the opposing side legs 414 and 418 of the repair loop 222(instead of the transversely disposed sacrificial loop 502).

Similar to the sacrificial loop 502, the sacrificial stitch 602 can beassociated with the repair loop 222 at a location between the bottomsurface 322 of the cortical button 210 and a proximal surface of thetissue graft 202 captured with the repair loop 222. The sacrificialstitch 602 can include any number of stitches formed by the sacrificialfilament, and thus references to a “stitch” is by no means limiting to asingle stitch. In the illustrated embodiment, three stitches of thesacrificial stitch 602 are visible, but more or fewer, including aslittle as a single stitch, are possible. The number of stitches used candepend on a variety of factors, including but not limited to the desiredstrength of the sacrificial stitch 602 in comparison to the desiredstrength of the repair loop 222, the type of procedure in which thestitch 602 is being used, the anatomy and tendencies of the patient, andthe preferences of the surgeon, among other factors.

The sacrificial stitch 602 can be formed in a variety of ways. By way ofnon-limiting example, the stitch may be passed through one of theopposing side legs 414, 418 just a single time before extending towardthe other opposing side leg 414, 418 and passing through the otheropposing side leg 414, 418 at least once. In other instances, the stitchmay pass through one of the opposing side legs 414, 418 multiple timesbefore extending toward the other opposing side leg 414, 418 and passingthrough the other opposing side leg 414, 418 at least once. In eitherinstance, the stitch can, but does not have to, return back to the firstopposing side leg for one or more additional stitches. In someinstances, rather than passing the stitch(es) through the opposing sideleg, they can be wrapped around the leg or otherwise associated with thelegs using techniques known to those skilled in the surgical filamentfield.

No matter how the sacrificial stitch 602 is associated with the repairloop 222, the two can be associated in such a manner that a desiredamount of constriction can be formed. This desired amount is similar toas described above with respect to the sacrificial loop 502, and thus itis understood it can result in various configurations, includinginstance in which the opposing side legs 414, 418 are touching at leastone location and instances in which a space S′ is disposed between theopposing side legs 414, 418, where the space S′, sometimes referred toas a gap, is smaller than a space would exist between the side legs 414,418 if no sacrificial element was associated with the repair loop 222.

The sacrificial stitch 602 can be configured to have a maximumload-bearing capacity that is lower than the maximum load-bearingcapacity of the repair loop 222 so that the sacrificial stitchproactively breaks before the repair loop fails (the terminologysurrounding the discussion of a threshold force above is equallyapplicable to this embodiment). For example, when the tissue graft 202pulls in a direction away from the cortical button 210, in a directionD″, the graft exerts a force on the distal end 406 of the repair loop222 that causes the repair loop to stretch both distally and laterally.As the repair loop 222 stretches laterally, the constricted side legs416, 418 exert opposing forces against the sacrificial stitch 602, andthereby causing the stitch to be stretched in opposite directions. Oncethe applied force exceeds the maximum load-bearing capacity of thesacrificial stitch 602, the stitch breaks and thereby causes the patientto hear, feel or otherwise experience sensory feedback, e.g., a poppingsound and/or an uneasy feeling or sensation, while the repair loop 222remains intact. Accordingly, as discussed above with reference to FIGS.4A and 4B, the sensory feedback associated with the broken sacrificialstitch 602 can serve as warning to the patient to avoid certainmovements or physical activity that can cause the tissue graft repair tofail.

Further, in instances in which the sacrificial stitch 602 includesmultiple stitches, the stitches can be similar to the loops 232 and 502that have multiple loops in that the stitches can be configured to havesimilar threshold force values or graduated threshold force values. In agraduated threshold force value configuration, different stitches of thesacrificial stitch 602 can have different threshold values such thatdifferent stitches break under different values of force applied to thesacrificial stitch 602.

Yet another non-limiting example of a sacrificial filament configurationis provided for in FIGS. 7A and 7B, in which the sacrificial filamentincludes a sacrificial weld 702 associated with the repair loop 222. Asshown, a surgical implant 700 includes the cortical button or body 210,the repair loop 222, and the sacrificial weld 702 associated with eachof the opposing side legs 414, 418 of the repair loop 222. The surgicalimplant 700 is similar to the surgical implants 500, 600 as shown anddescribed above with respect to FIGS. 5A and 5B and 6A and 6B,respectively, however, the sacrificial weld 702 constricts the opposingside legs 414 and 418 of the repair loop 222 (instead of thetransversely disposed sacrificial loop 502 and the sacrificial stitch602).

Similar to the sacrificial loop 502 and stitch 602, the sacrificial weld702 can be associated with the repair loop 222 at a location between thebottom surface 322 of the cortical button 210 and a proximal surface ofthe tissue graft 202 captured with the repair loop 222. Further,although the illustrated embodiment illustrates a single weld, a personskilled in the art will appreciate multiple welds can be used,depending, at least in part, on factors such as the desired strength ofthe sacrificial weld 702 in comparison to the desired strength of therepair loop 222, the type of procedure in which the weld 702 is beingused, the anatomy and tendencies of the patient, and the preferences ofthe surgeon, among other factors.

Similar to both the sacrificial loop 502 and the sacrificial stitch 602,the sacrificial weld 702 can be associated with the repair loop 222 at alocation between the bottom side 322 of the cortical button 210 and aproximal surface of the tissue graft 202 captured within the repair loop222. Further, a person skilled in the art will also understand varioustechniques that can be used to form one or more welds in conjunctionwith filament. By way of non-limiting example, a suture welding devicethat includes a heating element can be used to melt a portion of anoutside component, such as another filament or other material, toconstrict the opposing side legs 414, 418 of the repair loop 222. By wayof further non-limiting example, a suture welding device that includes aheating element can be used to melt a portion of one or both of theopposing side legs 414, 418 of the repair loop 222 to the other leg.

No matter how the sacrificial weld 702 is associated with the repairloop 222, the two can be associated in such a manner that a desiredamount of constriction can be formed. This desired amount is similar toas described above with respect to the sacrificial loop 502 and thesacrificial stitch 602, and thus it is understood it can result invarious configurations having a designated amount of space S″therebetween, sometimes referred to as a gap, or no space or gap at allin some instances.

The sacrificial weld 702 can have a maximum load-bearing capacity thatis lower than the maximum load-bearing capacity of the repair loop 222so that the sacrificial weld can proactively break before the repairloop fails (the terminology surrounding the discussion of a thresholdforce above is equally applicable to this embodiment). For example, whenthe tissue graft 202 pulls in a direction away from the cortical button210, in a direction D′″, the graft exerts a force on the distal end 406of the repair loop 222 that causes the repair loop to stretch bothdistally and laterally. As the repair loop 222 stretches laterally, theconstricted side legs 416, 418 exert opposing forces against thesacrificial weld 702, and thereby cause the stitch to be stretched inopposite directions. Once the applied force exceeds the maximumload-bearing capacity of the sacrificial weld 702, the weld breaks andthereby causes the patient to hear, feel or otherwise experience sensoryfeedback, e.g., a popping sound and/or an uneasy feeling or sensation,while the repair loop 222 remains intact. Accordingly, as discussedabove with reference to FIGS. 4A and 4B, the sensory feedback associatedwith the broken sacrificial weld 702 can serve as warning to the patientto avoid certain movements or physical activity that can cause thetissue graft repair to fail.

Further, in instances in which the sacrificial weld 702 includes aplurality of welds, the welds can be similar to the loops 232 and 502and the stitch 602 that have multiple loops and stiches, respectively,in that the welds can be configured to have similar threshold forcevalues or graduated threshold force values. In a graduated thresholdforce value configuration, different welds of the sacrificial weld 702can have different threshold values such that different welds breakunder different values of force applied to the sacrificial weld 702.

Still another non-limiting example of a sacrificial filamentconfiguration is provided for in FIGS. 8A and 8B, in which an operativefilament 810 includes both a repair filament 820 and a sacrificialfilament 830, with the sacrificial filament 830 being configured toproactively break before the repair filament 820. As shown, a surgicalimplant 800 includes a cortical button or body 210 and the operativefilament 810 coupled thereto. More specifically, the operative filament810 can include the repair filament 820 being associated or otherwiseintegrated with the sacrificial filament 830 to form an integratedrepair loop (the operative filament 810 may also be referred to as theintegrated repair loop 810, among other names in view of the way inwhich the repair and sacrificial filaments 820 and 830 are combined). Aperson skilled in the art, in view of the present disclosure, willunderstand a variety of ways by which the repair and sacrificialfilaments 820 and 830 can be integrated, including but not limited tobeing intertwined, braided, woven, and wrapped with respect to eachother, among other known manufacturing techniques. In the illustratedembodiment, the integrated repair loop 810 can include a proximal end812 extending along a top surface 320 of the cortical button 210, afirst side leg 814 extending from the top surface 320 through the firstthru-hole 316 b towards the tissue graft 202, a distal end 816 extendingaround a distal surface of the tissue graft 202, and a second side leg818 extending from the tissue graft 202 to the bottom surface 322 of thebutton and through the second thru-hole 316 c to complete the loop.Further, although in the illustrated embodiment the integrated repairloop 810 includes a single repair filament 820 and a single sacrificialfilament 830, a person skilled in the art will recognize multiple repairfilaments and/or sacrificial filaments can be formed into the integratedrepair loop 810 such that there are multiple integrated repair filamentsand/or sacrificial filaments.

The sacrificial filament 830 can be configured to have a lower maximumload-bearing capacity than the repair filament 820 so that thesacrificial filament of the integrated repair loop 810 proactivelybreaks before the repair filament of the loop 810 fails (the terminologysurrounding the discussion of a threshold force above is equallyapplicable to this embodiment). For example, when the tissue graft 202pulls in a direction away from the cortical button 210, in a directionD″, the graft exerts a force on the distal end 816 of the integratedrepair loop 810 that causes the loop to stretch. Once the applied forceof the tissue graft 202 exceeds the maximum load-bearing capacity of thesacrificial filament 830, the sacrificial filament breaks and therebycausing the patient to hear, feel or otherwise experience sensoryfeedback, e.g., a popping sound and/or an uneasy feeling or sensation.Because the sacrificial filament 830 is configured to break at loadsthat do not break the repair filament 820, the sacrificial filament 830can break while the repair filament 820 of the integrated repair loop810 remains intact and thereby maintains the attachment between thecortical button 210 and the tissue graft 202.

As previously discussed with reference to FIGS. 4A and 4B, thesacrificial filament 830 can be configured to have a lower maximumload-bearing capacity than the repair filament 820 using a variety oftechniques. These techniques may include, but are not limited to, usinga filament material for the sacrificial filament 830 having a modulus ofelasticity that is less than the modulus of elasticity of the repairfilament 820, using a filament material for the sacrificial filament 830having a diameter or thickness that is smaller than the diameter orthickness of the repair filament 820, and/or using a filament materialfor the sacrificial filament 830 having a different configuration thanthe repair filament 820 (e.g., the repair filament 820 is integratedmore tightly than the sacrificial filament 830, the repair filament 820is integrated and the sacrificial filament 830 is not).

In some embodiments of the variously illustrated implants 400, 500, 600,700, and 800 of FIGS. 4A-8B, the maximum load-bearing capacity of thesacrificial filament 830 can be about approximately one half of themaximum load-bearing capacity of the repair filament 220, 820. Forexample, for anterior or posterior cruciate ligament repairs, themaximum load-bearing capacity of the sacrificial filament 230, 502, 602,702, 830 can be approximately in the range of about 100 Newtons (N) toabout 1000 N, and in some embodiments it can be about 250 N, and themaximum load-bearing capacity of the repair filament 220, 820 can beapproximately in the range of about 1000 N to about 2500 N, and in someembodiments it can be about 1500 N. Alternatively, in some embodimentsthe maximum load-bearing capacity of the sacrificial filament 230, 502,602, 702, 830 can be less than one half of the maximum load-bearingcapacity of the repair filament 220, 820, while in still otherembodiments the maximum load-bearing capacity of the sacrificialfilament 230, 502, 602, 702, 830 can be more than one half but less thanthe maximum load-bearing capacity of the repair filament 220, 820.

The present disclosure also provides for sacrificial elements that arepart of the implantable body itself. By way of example, FIGS. 9A and 9Billustrate a surgical implant 900 that includes a suture or bone anchor910 having both a filament engagement mechanism 920 and a sacrificialfilament engagement mechanism 930. While the illustrated embodiment onlyprovides for a cross-sectional view of the anchor, a person skilled inthe art will understand many different types of suture anchors andconfigurations that can be representative of, or adapted in view of, theillustrated embodiment. The anchor 910 can be engaged by a repairfilament 940, which as shown in FIG. 9 can start by being engaged to thesacrificial filament engagement mechanism 930. The repair filament 940can be used in a variety of tissue repair techniques, and may or may notinvolve the use of a graft. As described further below, the implant 900can be configured such that the sacrificial filament engagementmechanism 930 breaks or otherwise allows the repair filament 940 to moveto the filament engagement mechanism 920 when a threshold force value isexceeded.

In the illustrated embodiment of FIG. 9A, the suture anchor 910 includesan axial bore or passageway 912 formed therethrough from a proximal end910 p to a distal end 910 d. In other embodiments, the bore may only bepartially formed therethrough. The filament engagement mechanisms 920and 930 can be transversely disposed across the axial bore 912 such thatthe sacrificial filament engagement mechanism 930 is spaced distallybelow and apart from the filament engagement mechanism 920. In someembodiments, the space or gap G 914 between the filament engagementmechanisms 920 and 930 can be approximately in a range from about 0.1 mmto about 1 mm.

In some embodiments, one or both filament engagement mechanisms 920, 930can be a post, saddle, crossbar, shaft, rod, spoke, or other rigidstructure for coupling a filament to a suture anchor. Such mechanisms920, 930 can be integrally formed parts or components of a sutureanchor, or, alternatively, one or both mechanisms 920, 930 can beseparate parts or components that are designed to be connected,attached, fixed, or otherwise coupled to a suture anchor. A personskilled in the art will understand many different types of filamentengagement mechanisms that can be used as part of a suture anchor,whether integrally or separately formed, and thus the presentillustrations and descriptions are by no means limiting. Further,although in the illustrated embodiment the filament engagementmechanisms 920 and 930 are of a similar type, they can be differenttypes, configurations, sizes, shapes, etc.

In the illustrated embodiment, the repair filament 940 is slidablyattached to the anchor 910 by extending the repair filament 940 into theaxial bore 912 and around the sacrificial filament engagement mechanism930. With the sacrificial filament engagement mechanism 930 intact, thedistal end 942 of the repair filament 940 is spaced apart from thefilament engagement mechanism 920 by the distance of the gap G. Theterminal ends 944 and 946 of the repair filament 940 can be manipulatedin a number of different ways known to those skilled in the art tosecure soft tissue (or possibly a graft) to bone, including but notlimited to the teachings of U.S. Pat. Nos. 8,814,905, 8,821,543,8,894,684, 9,095,331, 9,060,763, 9,345,468, 9,763,655 and U.S. PatentApplication Publication No. 2017/0215864, the contents of each which isincorporated by reference herein in its entirety.

The sacrificial filament engagement mechanism 930 can be configured tohave a maximum load-bearing capacity that is lower than the maximumload-bearing capacity of the filament engagement mechanism 920. Therespective load-bearing capacities of the filament engagement mechanisms920 and 930 can be defined as the maximum stress (e.g., force) or strain(e.g., deformation) that the filament engagement mechanism can standwithout breaking or otherwise failing. For example, when the repairfilament 940 exerts a force on the filament engagement mechanism 930 ina direction P, towards the filament engagement mechanism 920, the distalend 942 of the repair filament 940 exerts a force on the sacrificialfilament engagement mechanism 930. Once the applied force of the repairfilament 940 exceeds the maximum load-bearing capacity of thesacrificial filament engagement mechanism 930, the sacrificial filamentengagement mechanism 930 breaks or otherwise fails such that thesacrificial filament engagement mechanism 930 can no longer support therepair filament 940, thus releasing the repair filament 940. This canalso be referred to as a threshold force, which is the minimum amount offorce that can be applied to the sacrificial filament engagementmechanism to cause it to break. Forces greater than the threshold forcemay also cause the sacrificial filament engagement mechanism to break,while forces less than the threshold force are not, at least alone,large enough to cause the sacrificial filament engagement mechanism tobreak. Once the sacrificial filament engagement mechanism breaks, theapplication of the force in the direction P can cause the repairfilament 940 to be engaged or otherwise captured by the filamentengagement mechanism 920, which can subsequently maintain a location ofthe repair filament 940 with respect to the anchor 910 because itsthreshold value, or maximum load-bearing capacity, exceeds that of thesacrificial filament engagement mechanism 930.

A person skilled in the art will recognize there are a number ofdifferent ways by which the sacrificial filament engagement mechanism930 and the filament engagement mechanism 920 can be constructed so thatthey have different load-bearing capacities. In some embodiments, thesacrificial filament engagement mechanism 930 can be configured to havea lower maximum load-bearing capacity by using a material having amodulus of elasticity that is less than the modulus of elasticity of thefilament engagement mechanism 920. Additionally or alternatively, thesacrificial filament engagement mechanism 930 can be configured to havea lower maximum load-bearing capacity by using reducing the diameter orthickness of the sacrificial filament engagement mechanism 930 to besmaller than the diameter or thickness of the filament engagementmechanism 920. By way of further non-limiting example, the sacrificialfilament engagement mechanism 930 can include one or more pre-formedbreaking points manufactured or otherwise formed therein than allow itto break when a certain threshold force is applied to it. Other ways ofmaking the two filament engagement mechanism 920 and 930 have differentthreshold values for load-bearing are derivable in view of the presentdisclosures and knowledge of a person skilled in the art, and thus suchincorporation of the techniques is within the spirit of the presentdisclosure.

In some embodiments, the maximum load-bearing capacity of thesacrificial filament engagement mechanism 930 can be about approximatelyone half of the maximum load-bearing capacity of the filament engagementmechanism 920. For example, for rotator cuff repairs, the maximumload-bearing capacity of the sacrificial filament engagement mechanism930 can be approximately in the range of about 50 Newtons (N) to about500 N, and in some embodiments it can be about 150 N, and the maximumload-bearing capacity of the filament engagement mechanism 920 can beapproximately in the range of about 100 N to about 1000 N, and in someembodiments it can be about 300 N. Alternatively, in some embodiments,the maximum load-bearing capacity of the sacrificial filament engagementmechanism 930 can be less than one half of the maximum load-bearingcapacity of the filament engagement mechanism 920, while in still otherembodiments the maximum load-bearing capacity of the sacrificialfilament engagement mechanism 930 can be more than one half but lessthan the maximum load-bearing capacity of the filament engagementmechanism 920.

When the sacrificial filament engagement mechanism 930 breaks, thepatient may hear, feel, or otherwise experience some form of sensoryfeedback. For example, in some embodiments, the sensory feedback may bea sound (e.g., a popping sound) of the sacrificial filament engagementmechanism 930 breaking. In some embodiments, the patient may feel aslight movement of the repair filament 940 in response to the distal end942 of the repair filament 940 being released from the sacrificialfilament engagement mechanism 930 until captured by the filamentengagement mechanism 920. Thus, the sensory feedback associated with thesacrificial filament engagement mechanism 930 breaking can serve as awarning that the patient's physical activity or movements may riskfailure of the tissue graft repair. The warning may also cause patientsto seek out medical attention or advice.

A person skilled in the art will appreciate that the various sacrificialelements provided for herein can be used in conjunction with each other.For example, both a sacrificial filament (e.g., the sacrificial elements230, 502, 602, 702, 830) and a sacrificial engagement mechanism (e.g.,the sacrificial engagement mechanism 930) can both be incorporated withor otherwise used in conjunction with a single implant. Likewise, morethan one configuration of a sacrificial filament (e.g., the sacrificialelements 230, 502, 602, 702, 830) can be used together in the sameimplant. In either or both instances, such a design can provideadditional fail-safes that break at approximately the same thresholdvalue of force, and/or they can be designed in a tiered configuration asprovided for above, in which one sacrificial element is designed to failat a first threshold value of force and another sacrificial element isdesigned to fail at a second threshold value of force that is greaterthan the first threshold value of force.

While a variety of uses are provided for above either in discussing thevarious embodiments or in the various patents and patent applicationsincorporated by reference, two general descriptions of a use of asurgical implant that includes a sacrificial element are provided below.The first describes a procedure involving an implant having at least onesacrificial filament associated therewith for use in conjunction with agraft, and the second describes a procedure involving an implant havingat least one sacrificial engagement mechanism that is part of a body ofthe implant for use in conjunction with repairing tissue. Because thegeneral surgical techniques for implanting a graft and repairing atissue are known, illustrations of the same are unnecessary. Theenhancements to these procedures will be evident from the disclosuresherein.

In one use, the implant is the implant 200 having an implant body 210, arepair filament 220, and a sacrificial filament 230, as shown in FIG.4A. A person skilled in the art will recognize these descriptions of usecan be applied without much difficulty to the other configurationsprovided for herein (e.g., the implants 500, 600, and 700) or otherwisederivable from the present disclosures. To start, desired tunnels andbores can be formed at the surgical site to provide a location at whicha graft 202 will be disposed. The tunnels and bores formed will depend,at least in part, on the type of procedure being performed. Someexemplary procedures can include ligament repair procedures, such ascruciate ligament procedures using a ligament graft(s) (e.g., ACL andMCL procedures). In some embodiments, at least one bone tunnel in atleast one bone can be formed. The implant 200 can be implanted withrespect to the bone tunnel such that the implant body 210 rests againstthe bone proximate to one end of the bone tunnel and the repair filament220 and the sacrificial filament 230 extend away from the implant body210 and into the bone tunnel. In some instances the implant body 210 canbe passed into and through the bone tunnel, beginning at the oppositeend from where it rests against the bone, while in other instances theimplant body can be positioned at its resting location with thefilaments 220 and 230 being manipulated into the bone tunnel.

A graft 202 can be coupled to the implant 200 by associating the graft202 with the sacrificial filament 230. The association can occur priorto, during, or after the body 210 is passed into the bone tunnel. By wayof non-limiting example, in instances in which the implant body 210 ispassed into and through the bone tunnel, the graft 202 can be associatedor otherwise coupled to the sacrificial element 230 prior to positioningthe implant body at the opposite end where it rests such that thesacrificial element 230 and graft 202 are passed through at least aportion of the bone tunnel while associated with each other. Theassociation of the sacrificial element 230 and graft 202 can be achievedin a variety of manners. By way of non-limiting examples, a portion ofthe graft 202 can be passed through an opening of the loop 232 formed bythe sacrificial filament 230 and/or a portion of the sacrificialfilament 230 can be passed through the graft 202 itself. The rest of thesurgery can be performed to position the graft at the desired locationwith respect to the bone and the bone tunnel. Any openings formed in thebody to perform the procedure can be closed, with the net result beingthe implant 200 holding the graft 202 by way of the sacrificial filament230 in the bone tunnel and the repair filament 220 being disposed somedistance away from graft 202, as illustrated the distance H in FIG. 4A,the repair filament 220 also being disposed in the bone tunnel.

Following the completion of the procedure, if a movement is made by thepatient that causes a force applied to sacrificial element 230 by thegraft 202 to exceed the threshold force of the sacrificial element 230,the sacrificial element 230 is configured to break, as shown in FIG. 4B.This results in the graft 202 being let loose and traveling the distanceH until it engages the repair filament 220. The repair filament 220 cancatch and hold the graft 202, thus maintaining the integrity of theprocedure. The distance H can be such that the movement for that lengthdoes not cause any serious ramifications to the patient due to themovement of the graft 202 that amount. As discussed above, the breakingof the sacrificial element 230 can cause some sort of signal to thepatient (e.g., auditory, feeling, etc.) to let the patient know themovement that resulted in the breaking of the sacrificial element 230was not desirable and should be avoided in the future. The patient canalso use this signal to notify the appropriate medical provider so anyother recommended actions can be carried out or conveyed to the patient.

In another use, the implant is the implant 900 having a suture anchor910, a filament engagement mechanism 920, a sacrificial filamentengagement mechanism 930, and a repair filament 940, as shown in FIG.9A. To start, desired bone holes or tunnels can be formed at thesurgical site to provide a location at which the suture anchor 910 willbe disposed. The bores and tunnels formed will depend, at least in part,on the type of procedure being performed. Some exemplary procedures caninclude tissue repair procedures to repair complete or partialdetachments of tendons, ligaments, and other soft tissues from bones,such as for rotator cuffs and Achilles tendons. In some embodiments, atleast one bone bore is formed in the bone, the bore being designed toreceive the suture anchor 910. The implant 900 can be implanted withrespect to the bone bore using any technique known for inserting asuture anchor 910 into a bone bore, including a suture anchor inserterthat pushes and/or rotates the anchor 910 to a desired location withinthe bore.

The repair filament 940 can extend from the anchor 910, away from thebone and its bore. The repair filament can be coupled to the anchor 910by way of the sacrificial filament engagement mechanism 930. Theassociation can occur prior to, during, or after the anchor 910 ispassed into the bone bore. Thus, in some instances the repair filament940 may be disposed around at least a portion of the sacrificialfilament engagement mechanism 930 prior to disposing the anchor 910 inthe bore, while in other instances the repair filament 940 may bedisposed around at least a portion of the sacrificial filamentengagement mechanism 930 after the anchor 910 has been disposed in thebore.

Once the anchor 910 and repair filament 940 are located in their desiredlocations, the remainder of the procedure can be performed. This caninclude manipulating the repair filament 940 or associated tissue toeventually draw the tissue towards the bone in which the anchor 910 isimplanted. Alternatively, the location at which the tissue is to bedisposed can be a location that is not the bone in which the anchor 910is implanted. For example, the anchor 910 could be disposed in a boneproximate to the desired location of the tissue because the bone inwhich the anchor 910 is disposed provides for a more stable environmentfor the anchor 910 than the bone at which the tissue is to be disposed.The purpose of the present disclosure, nevertheless, is achieved even ifthe bone in which the anchor 910 is disposed is different than the boneto which the tissue is to be drawn. Any techniques for drawing tissue tobone using filament can be used. Once the rest of the surgery iscompleted, any openings formed in the body to perform the procedure canbe closed, with the net result being the anchor 910 holding the repairfilament 940 by way of the sacrificial filament engagement mechanism 930and the repair filament 940 holding the location of tissue beingrepaired at a desired location with respect to bone. The filamentengagement mechanism 920 is disposed at a location more proximate to thetissue than the sacrificial filament engagement mechanism 930 islocated, as illustrated by the distance G in FIG. 9A.

Following the completion of the procedure, if a movement is made by thepatient that causes a force applied to sacrificial filament engagementmechanism 930 by the repair filament 940 to exceed the threshold forceof the sacrificial filament engagement mechanism 930, the sacrificialfilament engagement mechanism 930 is configured to break, as shown inFIG. 9B. This results in the repair filament 940 being let loose andtraveling the distance G until it engages the filament engagementmechanism 920. The filament engagement mechanism 920 can catch and holdthe repair filament 940, thus maintaining the integrity of theprocedure. The distance G can be such that the movement for that lengthdoes not cause any serious ramifications to the patient due to themovement of the repair filament 940, and thus possibly the associatedtissue, that amount. As discussed above, the breaking of the sacrificialfilament engagement mechanism 930 can cause some sort of signal to thepatient (e.g., auditory, feeling, etc.) to let the patient know themovement that resulted in the breaking of the sacrificial filamentengagement mechanism 930 was not desirable and should be avoided in thefuture. The patient can also use this signal to notify the appropriatemedical provider so any other recommended actions can be carried out orconveyed to the patient.

One skilled in the art will appreciate further features and advantagesof the disclosure based on the above-described embodiments. Accordingly,the disclosure is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. For example,to the extent the present disclosure disclose using the devices andmethods provided for herein for soft tissue repairs associated with theknee and shoulder, a person skilled in the art will recognize how thepresent disclosures can be adapted for use with other anatomies. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A surgical implant, comprising: an implantablebody having at least one passageway extending at least partiallytherethrough; a repair filament disposed in the at least one passagewayof the implantable body, the repair filament forming a repair loopconfigured to connect the implantable body and a tissue, the repairfilament having a first maximum load-bearing capacity; and a sacrificialelement associated with at least one of the implantable body and therepair filament, the sacrificial element being configured to carry anapplied load of at least one of the repair filament and the tissue, thesacrificial element having a second maximum load-bearing capacity thatis lower than the first maximum load-bearing capacity of the repairfilament such that the sacrificial element is configured to producesensory feedback in response to the applied load of the at least one ofthe repair filament and the tissue exceeding the second maximumload-bearing capacity.
 2. The surgical implant of claim 1, wherein thesacrificial element comprises a sacrificial filament.
 3. The surgicalimplant of claim 2, wherein the at least one passageway comprises atleast two passageways, each passageway extending between a proximal endand a distal end of the implantable body, each of the repair filamentand the sacrificial filament extending through each of the at least twopassageways such that each of the repair filament and the sacrificialfilament is disposed above a top side of the implantable body and belowa bottom side of the implantable body, the top and bottom sides beingopposed to each other, wherein the sacrificial filament forms asacrificial loop configured to produce the sensory feedback in responseto an applied load from the tissue when the applied load exceeds thesecond maximum load-bearing capacity of the sacrificial filament.
 4. Thesurgical implant of claim 3, wherein the sensory feedback is associatedwith the sacrificial loop breaking in response to the applied load fromthe tissue when the applied load exceeds the second maximum load-bearingcapacity of the sacrificial filament.
 5. The surgical implant of claim3, wherein a circumference formed by the sacrificial loop is smallerthan a circumference formed by the repair loop.
 6. The surgical implantof claim 2, wherein the second maximum load-bearing capacity of thesacrificial filament is approximately one half of the first maximumload-bearing capacity of the repair filament.
 7. The surgical implant ofclaim 2, wherein the sacrificial filament is configured to form asacrificial loop disposed approximately transverse to the repair loop,the sacrificial loop constricting opposing sides of the repair loop at alocation between the implantable body and a distal end of the repairloop.
 8. The surgical implant of claim 7, wherein the sensory feedbackis associated with the sacrificial loop breaking in response to theopposing sides of the repair loop stretching the sacrificial loop untilthe second maximum load-bearing capacity of the sacrificial filament isexceeded.
 9. The surgical implant of claim 2, wherein the sacrificialfilament is configured to form one or more sacrificial stitchesconnecting opposing sides of the repair loop at a location between theimplantable body and a distal end of the repair loop.
 10. The surgicalimplant of claim 9, wherein the sensory feedback is associated with atleast one sacrificial stitch of the one or more sacrificial stitchesbreaking in response to the opposing sides of the repair loop stretchingthe at least one sacrificial stitch until the second maximumload-bearing capacity of the sacrificial filament is exceeded.
 11. Thesurgical implant of claim 2, wherein the sacrificial filament isintegrated with the repair filament to form a sacrificial loopintegrated with the repair loop.
 12. The surgical implant of claim 11,wherein the sensory feedback is associated with the sacrificial loopbreaking while the repair loop remains intact in response to the tissueapplying a load greater than the second maximum load-bearing capacity ofthe sacrificial filament and less than the first maximum load-bearingcapacity of the repair filament.
 13. The surgical implant of claim 1,wherein the sacrificial element comprises a sacrificial weld thatconnects opposing sides of the repair loop at a location between theimplantable body and a distal end of the repair loop.
 14. The surgicalimplant of claim 13, wherein the sensory feedback is associated with thesacrificial weld breaking in response to the opposing sides of theload-bearing loop stretching the sacrificial weld until the secondmaximum load-bearing capacity of the sacrificial weld is exceeded. 15.The surgical implant of claim 1, wherein the implantable body comprisesa suture anchor that includes the sacrificial element and a filamentengagement mechanism, and wherein the sacrificial element comprises asacrificial filament engagement mechanism.
 16. The surgical implant ofclaim 15, wherein the sacrificial filament engagement mechanism isdistally spaced apart from the filament engagement mechanism, whereinthe second maximum load-bearing capacity of the sacrificial filamentengagement mechanism is lower than a maximum load-bearing capacity ofthe filament engagement mechanism, wherein the repair filament isdisposed at least partially around each of the filament engagementmechanism and the sacrificial filament engagement mechanism, with adistal-most portion of the repair filament being engaged with thesacrificial filament engagement mechanism, and wherein the sensoryfeedback is associated with the sacrificial filament engagementmechanism breaking in response to the repair filament applying a forceagainst the sacrificial filament engagement mechanism that exceeds thesecond maximum load-bearing capacity of the sacrificial filamentengagement mechanism.